January 15, 2010 - This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the 11/2009 version of the PHS 398 application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the 11/2007 version of the PHS 398 application forms and instructions.

Key Dates
Release/Posted Date: November 12, 2008Letters of
Intent Receipt Date(s): December 28, 2008; April 28, 2009; August
29, 2009; December 28, 2009; April 28, 2010; August 28, 2010; December 28,
2010; April 30, 2011; August 28, 2011.Application Due Date(s): January
28, 2009; May 28, 2009; September 29, 2009; January 28, 2010; May 28, 2010;
September 28, 2010; January 28, 2011; May 27, 2011; September 28, 2011.AIDS
Application Due Date(s): May 4, 2009; September 2, 2009; January 5, 2010; May 4,
2010; September 1, 2010; January 5, 2011; May 3, 2011; September 1, 2011;
January 4, 2012.Peer Review Date(s): June/July 2009; October/November 2009; February/March 2010; June/July 2010;
October/November 2010; February/March 2011; June/July 2011; October/November
2011; February/March 2012.Council Review Date(s): October
2009; January 2010; May 2010; October 2010; January 2011; May 2011; October
2011; January 2012; May 2012.Earliest Anticipated
Start Date(s): December 2009; April 2010; July 2010; December 2010;
April 2011; July 2011; December 2011; April 2012; July 2012.Additional
Information To Be Available Date (Activation Date):Not
Applicable.Expiration Date:
January 5, 2012.

Due Dates for
E.O. 12372

Not
Applicable.

Additional Overview
Content

Executive Summary

Purpose. With this Funding
Opportunity Announcement (FOA), the National Cancer Institute (NCI) invites applications for investigator-initiated program project (P01) grants. Proposed
program projects may address any of the broad areas of cancer research,
including (but not limited to) cancer biology, cancer treatment, cancer
diagnosis, cancer prevention, and cancer control. Basic,
translational, clinical, and/or population-based studies in all of these
research areas are appropriate. Each Program Project application must consist
of at least three component projects. The component projects must share a
common central theme, focus, and/or overall objective.

Mechanism
of Support.This FOA will
utilize the NIH Program Project (P01) grant mechanism.

Funds Available and Anticipated Number
of Awards.Awards issued under this FOA are contingent upon the
availability of funds and the submission of a sufficient number of meritorious
applications.

Budget
and Project Period. Applicants may request support for up to
5 years. Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and duration of
each award will also vary.

Research Strategy Page Limitations. For
specific limits, see Section IV. 2. Content and Form of Application Submission.

Eligible Project
Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources
necessary to carry out the proposed research are invited to work with their
institution/organization to develop an application for support. Individuals
from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Number of PDs/PIs. More than one PD/PI,
or multiple PDs/PIs, may be designated on the application.

Number
of Applications. Applicants may submit
more than one application, provided that each application is scientifically
distinct.

Resubmissions. Resubmission
applications will be accepted. Such applications must include an Introduction
addressing the previous peer review critique (Summary Statement).

Renewals.Renewal applications are permitted in
response to this FOA.

See Section
IV.1 for application materials. All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the current forms and instructions.

Hearing Impaired. Telecommunications for the
hearing impaired are available at: TTY 301-451-5936.

This Funding
Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI),
invites grant applications for investigator-initiated Program Projects (P01) in any area of
cancer research. P01 grants support
integrated, multiproject research programs involving a number of independent
investigators who share knowledge and common resources while working towards a
unifying overall scientific goal. Therefore, every P01 program project
proposed should have a well-defined unifying research theme.

Each Program Project application must include
at least three component projects. The individual projects may represent
several disciplines and/or address several discrete research aspects pertinent
to one or more disciplines. However, all of the projects must be relevant to
the common unifying central theme, focus, and the overall objective of the
entire program project. Each individual project should reflect a self-standing
scientifically meritorious research effort. In addition, however, the
individual projects should be clearly interrelated and synergistic so that the
research ideas, efforts, and outcomes of the program as a whole will offer a
distinct advantage over pursuing the individual projects separately.

Specific Research Objectives

This FOA invites multidisciplinary
coordinated research programs in any of the broad areas of cancer research,
including but not limited to studies of cancer biology, cancer treatment,
cancer diagnosis, cancer prevention, and cancer control. Basic,
translational, clinical, and/or population-based studies in all of these
research areas are appropriate.

Minimum Number of Research Projects
(Required): Each P01 application submitted in response to this FOA must include at least
three related research projects. The projects must share a common central
theme, focus, and/or overall objective.

Shared
Resource Core(s) (optional): In addition to individual research projects,
applicants may propose one or more Shared Resource Cores if needed for the
proposed research. Both administrative and research support cores are
allowed. Each Shared Resource Core must provide support and enhance the
productivity, cost-effectiveness, and/or research outcome of at least two of
the proposed research projects. New cores may be proposed and/or existing
cores may be augmented to support the proposed research.

Multiple
Program Directors/Principal Investigators (PDs/PIs): The NCI encourages P01 program
project applicants to take advantage of the multiple PDs/PIs option. The use
of this option allows, for example, the designation of any (or all) of the
leaders of the individual projects or cores as a PD/PI of the overall
application. If this option is used, it is expected that one of the PDs/PIs
will be identified as the lead PD/PI who will be responsible for coordinating
the entire program project.

Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the NCI provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.

Note: Budgetary requests
for renewal P01 applications are subject to the NCI cap policy (see NOT-CA-08-026)
that limits the permissible increase in direct costs in the renewal
applications.

Although foreign institutions are not
eligible to apply, they may be involved in Program Projects proposed by
eligible Domestic institutions under subcontractual arrangements, if
appropriate.

1.B. Eligible Individuals

Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with his/her institution to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

More than one PD/PI, or multiple PDs/PIs, may
be designated on the application for programs that require a team science
approach and therefore clearly do not fit the single-PD/PI model.
Additional information on the implementation plans, policies and procedures to
formally allow more than one PD/PI on individual R01 research projects is
available at https://grants.nih.gov/grants/multi_pi.
All PDs/PIs must be registered in the NIH eRA Commons prior to the submission
of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for an NCI
P01 grant with a single PD/PI or multiple PDs/PIs is the responsibility of the
investigators and applicant organizations and should be determined by the
scientific goals of the program. Applications for grants with multiple PDs/PIs
will require additional information, as outlined in the instructions below.
When considering multiple PDs/PIs, please be aware that the
structure and governance of the PD/PI leadership team as well as the knowledge,
skills, and experience of the individual PDs/PIs will be factored into the
assessment of the overall scientific merit of the application. Multiple
PDs/PIs on a program share the authority and responsibility for leading and
directing the program, intellectually and logistically. Each PD/PI is
responsible and accountable to the grantee organization, or, as appropriate, to
a collaborating organization, for the proper conduct of the program, including
the submission of required reports. For further information on multiple
PDs/PIs, please see https://grants.nih.gov/grants/multi_pi.

Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.

The title and
number of this funding opportunity must be typed in item (box) 2 of the face page of the application form and the YES box must
be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued
page to provide Items 3a 3h for all PD/PIs. NIH requires one PD/PI be
designated as the contact PD/PI for all communications between the PD/PIs and
the agency. The contact PD/PI must meet all eligibility requirements for PD/PI
status in the same way as other PD/PIs, but has no special roles or
responsibilities within the project team beyond those mentioned above. The
contact PD/PI may be changed during the project period. The contact PD/PI
should be listed in block 3 of Form Page 1 (the Face Page), with all additional
PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI
in the header of each application page, use the name of the Contact PD/PI, et.
al. The contact PD/PI must be from the applicant organization if the PDs/PIs
are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will
not give the PD/PI the appropriate access to the application records). Each
PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to
include a new section describing the leadership plan approach for the proposed
project.

Supplemental
Instructions for the Preparation of Multi-Project Applications.

For all P01 applications
submitted in response to this FOA, the standard PHS 398 instructions are modified as summarized below, and as described in more detail
in the Guidelines for NCI P01s (go to http://deainfo.nci.nih.gov/awards/P01.pdf for SPECIAL
INSTRUCTIONS for PREPARATION of PROGRAM PROJECT APPLICATIONS). These additional instructions are required because the
PHS Form 398 is designed primarily for individual freestanding research project
grant applications, and does not have specific instructions for multi-project
applications.

Form Page 1 - Face
Page:
Include the number and title of this FOA in item/line 2 of the PHS 398
application face page.

Form Page 2 -
Description, Performance Sites, and Key Personnel: Under Description,
state the proposed programs broad, long-term objectives, specific aims, and
the significance to the field of cancer research. Define the relevance of each
proposed project and shared resource core to the overall theme and goals of the
program. List all performance sites and all Key Personnel and Other Significant
Contributors for the entire P01, beginning with the PI/PD(s) and then listing
all other Key Personnel alphabetically. Include all project and core leaders,
co-leaders, co-investigators, and consultants and consortium collaborators (if
applicable and if these individuals will devote measurable effort to the
project).

Form Page 3 - Table
of Contents: Modify the PHS 398 Form Page 3 to enable reviewers to find each component of
the application easily. A sample Table of Contents is included as Appendix
A in the Guidelines for NCI P01s as an example of the format for the Table of
Contents and how the application should be organized (see http://deainfo.nci.nih.gov/awards/P01.pdf).

Form Pages 4 and 5
Detailed Budget for Initial Budget Period; Budget for Entire Proposed Period of
Support: Prepare
a detailed composite budget for all requested support categories for the first
years using Form Page 4 and a summary budget for the entire proposed period of
support using Form Page 5 of the PHS 398 application. If applicable, provide
additional budget pages pertaining to Consortium/Contractual arrangements
(following the standard PHS 398 instructions).

Biographical
Sketches: Compile all biographical sketches after the Overall Budget, starting with the
PD(s)/PI(s) followed by all other investigators in alphabetical order. Do not
repeat biographical sketches in the individual research projects or shared
resources cores.

Program Overview:

Overall Aims:

Summarize the the overall theme, goals, specific aims
and expected impact of the proposed program on one or more broad fields of
cancer research (limited to one page).

Overall Research Strategy:

Summarize the overall research strategy, including the
overall significance, innovation, approaches, preliminary studies and
progress (for competing renewal applications) of the program as a whole,.
This section is limited to 12 pages excluding references and the list of
publications that resulted from work in the program during the current
funding period (for renewal applications).

Explain how the proposed projects and shared resource
cores (if proposed) will be coordinated and work together to address the
overall goals and aims of the program more effectively than if the projects
were done independently; Explain the plans for organizational and
administrative management of the overall program, and for coordination and
communication within the program. Explain the methods that will be used for
monitoring progress in the projects and effective use of the shared resource
cores. This section is limited to six pages.

The Overall Program Environment section should briefly
summarize the overall institutional environment, resources and commitments
that are relevant to effective implementation of the P01. Describe how the
proposed projects and shared resource cores will use the facilities and
resources available at the overall program level. Describe how the program
as a whole will benefit from any special equipment, laboratories, patient
populations, and collaborations.

Multiple
PI Leadership Plan (if applicable). If the multiple PDs/PIs option is used, the
new required section describing the Multiple PI Leadership Plan (see SPECIAL
INSTRUCTIONS below) should be inserted in the application after the Overall
Program Environment section. There is no page limit for this section, but applicants should be specific
and concise.

Individual Research
Projects:Each P01 program project application must include at
least three individual (albeit connected) research projects each of which is
pertinent to the central theme of the program. Each research project should be
prepared according to the standard PHS 398 instructions as modifiedin the Guidelines for NCI P01s (http://deainfo.nci.nih.gov/awards/P01.pdf: Instead of the standard PHS 398 face page for each
project, create a title page that lists the project number, the name of the
project, and the name of the project leader. Do not repeat biographical sketches included at the
beginning of the application. Do not
exceed 12 pages for Section 3, Research Strategy, of the research plan. Each Project
must have a single designated Project Leader.

Shared Resource
Cores: Applicants may propose one or
more (as needed) appropriate shared technical or administrative shared resources, cores.
These shared resources must not duplicate analogous resources already established in the
applicant institutions (although supplemental funding to such existing
resources may be requested). Each shared
resource core should be prepared according to the standard PHS 398 instructions as modifiedin
the Guidelines for NCI P01s (http://deainfo.nci.nih.gov/awards/P01.pdf:Instead of the standard
PHS 398 face page for each shared resource core, create a title page that lists the
shared resource core
number, the name of the shared resource core and the name of the shared
resource core director. Do not repeat biographical sketches
included at the beginning of the application. Do not exceed 12 pages for Item 3, Core Services Plan, of each core. Each shared resource core
must have a single designated Core Director.

Multiple PD/PI Leadership Plan: For applications
designating multiple PDs/PIs, a new section of the research plan, entitled Multiple
PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI
approach should be described. The governance and organizational structure of
the leadership team and the research project should be described, and should
include communication plans, process for making decisions on scientific
direction, and procedures for resolving conflicts. The roles and
administrative, technical, and scientific responsibilities for the project or
program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to
specific components of the project or the individual PDs/PIs should be
delineated in the Leadership Plan. In the event of an award, the requested
allocations may be reflected in a footnote on the Notice of Award.

3.A. Submission, Review, and Anticipated Start Dates Letters of Intent Receipt Date(s): December 28, 2008;
April 28, 2009; August 29, 2009; December 28, 2009; April 28, 2010; August 28,
2010; December 28, 2010; April 30, 2011; August 28, 2011.Application Due Date(s): January
28, 2009; May 28, 2009; September 29, 2009; January 28, 2010; May 28, 2010;
September 28, 2010; January 28, 2011; May 27, 2011; September 28, 2011.AIDS
Application Due Date(s): May 4, 2009; September 2, 2009; January 5, 2010; May 4,
2010; September 1, 2010; January 5, 2011; May 3, 2011; September 1, 2011;
January 4, 2012.Peer Review Date(s): June/July 2009; October/November 2009; February/March 2010; June/July 2010;
October/November 2010; February/March 2011; June/July 2011; October/November
2011; February/March 2012.Council Review Date(s): October
2009; January 2010; May 2010; October 2010; January 2011; May 2011; October
2011; January 2012; May 2012.Earliest Anticipated
Start Date(s): December 2009; April 2010; July 2010; December 2010;
April 2011; July 2011; December 2011; April 2012; July 2012.Additional
Information To Be Available Date (Activation Date):Not
Applicable.

3.A.1.
Letter of Intent

Prospective applicants are asked to submit a letter of
intent that includes the following information:

Descriptive title of proposed research;

Name, address, and telephone number of the
PD(s)/PI(s);

Names of other key personnel;

Participating institutions; and

Number and title of this funding opportunity
announcement.

Although a letter of intent is not required, is not
binding, and does not enter into the review of a subsequent application, the
information that it contains allows NCI staff members to estimate the potential
review workload and plan the review.

Applications
must be prepared using the research grant application forms found in the PHS
398 instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three
signed photocopies in one package to:

Applications must be received on or before the application
receipt/submission dates described above (Section
IV.3.A.). If an application is received after that date, it may be delayed in the review process or not reviewed.

Upon receipt,
applications will be evaluated for completeness by CSR. Incomplete
applications will not be reviewed.

The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial merit review unless the
applicant withdraws the pending application. The NIH will not accept any
application that is essentially the same as one already reviewed. However, the
NIH will accept a resubmission application, but such application must include
an Introduction addressing the critique from the previous review.

All NIH awards
are subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.

Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the
project; and 2) would be allowable under the grant, if awarded, without NIH
prior approval. If specific expenditures would otherwise require prior
approval, the grantee must obtain NIH approval before incurring the cost. NIH
prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new or
renewal award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project
(see the NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

6. Other Submission
Requirements and Information

Specific
Instructions for Applications Requesting $500,000 (direct costs) or More per
Year

Applicants
requesting $500,000 or more in direct costs for any year (excluding consortium
F&A costs) must carry out the following steps:

1) Contact the
NCI Referral Office at least 6 weeks before submitting the application, i.e.,
as plans are being developed for the study;

2) Obtain agreement
from the NCI staff that the NCI will accept the application for consideration
for award; and

3) Include a cover letter with the application that
identifies the NCI staff member who agreed to accept assignment of the
application.

This policy
applies to all new, renewal, revision, and resubmission applications. See NOT-OD-02-004, October 16, 2001.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations
may be delayed in the review process.

Submit the CD with all appendix materials in the package with the two copies of the application that is sent to the NCI Referral Office.

Resource Sharing
Plan(s)

NIH
considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value of, and advance,
research. When resources have been developed with NIH funds and the associated
research findings published or provided to NIH, it is important that they be
made readily available for research purposes to qualified individuals within
the scientific community. If the final data/resources
are not amenable to sharing, this must be explained in Resource Sharing section
of the application (see https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications where the development of
model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model
organisms and related resources, or state appropriate reasons why such sharing
is restricted or not possible. See Sharing
Model Organisms Policy and NIH
Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless
of the amount requested, applicants seeking funding for a genome-wide
association study are expected to provide a plan for submission of GWAS data to the NIH-designatedGWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. A
genome-wide association study is defined as any study of genetic variation
across the entire genome that is designed to identify genetic associations with
observable traits (such as blood pressure or weight) or the presence or absence
of a disease or condition. For further information see Policy for Sharing
of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088, and https://grants.nih.gov/grants/gwas/.

Section
V. Application Review Information

1.
Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria
described below will be considered in the review process.

2.
Review and Selection Process

Applications
that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group convened by the
National Cancer Institute and in accordance
with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As
part of the scientific peer review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned an impact/priority score;

Receive
a written critique; and

Receive a second level
of review by
the National Cancer Advisory Board.

Applications
submitted in response to this funding opportunity will compete for available
funds with all other recommended applications. The following will be
considered in making funding decisions:

Scientific
merit of the proposed project as determined by scientific peer review;

Availability
of funds; and

Relevance
of the proposed project to program priorities.

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance:Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s):Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD/PI(s) and
investigative team bring complementary and integrated expertise to the project
(if applicable)?

Innovation:Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach:Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) Protections for Human Subjects, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
For applications designating multiple PDs/PIs, is the leadership approach,
including the designated roles and responsibilities, governance, and
organizational structure, consistent with and justified by the aims of the
project and the expertise of each of the PDs/PIs?

Environment:Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In
addition to the standard NIH-wide criteria, the following criteria will be
used to evaluate specific aspects/components of the P01 application. The overall
application will be evaluated as an integrated research effort focused on a
central theme. Individual research projects, supporting cores (if proposed),
and Program as an Integrated Effort are collectively considered. The
relationship and contributions of each research project and core to the overall
theme of the program project will be discussed and evaluated. Although
projects not recommended for inclusion in the program are not considered in
scoring the overall program project, such projects may reflect on the
leadership capabilities of the PD(s)/PI(s).

A.
Review Criteria for the Overall Program as a Whole:

Significance: Does the program as a whole address an important
problem or a critical barrier to progress in the field? If the aims of the
program are achieved, how will scientific knowledge, technical capability,
and/or clinical practice be improved? How will successful completion of the
program change the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?

Investigator(s)/Overall Program Leadership: Are the qualifications of
the PD(s)/PI(s) and other senior scientists appropriate to lead the P01 and
coordinate all P01 activities? Do they provide effective scientific and
administrative leadership, as demonstrated by selection of individual
projects for scientific excellence and thematic relatedness? Is the
commitment (percent effort) of the PD(s)/PI(s) and other senior
investigators adequate?

Innovation: To what degree does the overall program challenge and seek
to shift current research or clinical practice paradigms by utilizing novel
theoretical concepts, approaches or methodologies, instrumentation or
interventions?

Approach: Is the overall design of the P)1, including strategies,
methodologies and analyses, well-reasoned and appropriate to accomplish the
specific aims of the program? What is the overall quality of the projects
and the adequacy of the services provided by the shared resource cores (if
proposed)? For competing renewal applications, has there been adequate
progress during the current funding period? For applications designating
multiple PDs/PIs, is the leadership approach, including the designated roles
and responsibilities, governance, and organizational structure, consistent
with and justified by the aims of the program and the expertise of each of
the PDs/PIs? If the program involves clinical research, are the plans for 1)
protection of human subjects from research risks, and 2) the inclusion of
minorities and members of both sexes/genders, as well as the inclusion of
children, justified in terms of the scientific goals and research strategy
proposed?

Environment: Will the scientific environment in which the work will
be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the
investigators adequate for the projects proposed? Will the program benefit
from unique features of the scientific environment, subject populations, or
collaborative arrangements? Is there evidence of sufficient institutional
support for the Program Project?

Integration: Is there evidence of scientific
and administrative integration of the proposed Program? Is there evidence of
coordination, interrelationships, and synergy among the individual research
projects and core components? Are there clear advantages or value added by
conducting the proposed research as a Program Project rather than through
separate research efforts? For competing renewal applications, is there
evidence of productive collaborations during the current funding period?

B. Review Criteria for Individual Research
Projects:

Significance: Significance Does the project address an important
problem or a critical barrier to progress in the field? If the aims of the
project are achieved, how will scientific knowledge, technical capability,
and/or clinical practice be improved? How will successful completion of the
aims change the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?

Investigator(s): Are the PD/PIs, collaborators, and other researchers
well suited to the project? If Early Stage Investigators or New
Investigators, do they have appropriate experience and training? If
established, have they demonstrated an ongoing record of accomplishments
that have advanced their field(s)? If the project is collaborative or
multi-PD/PI, do the investigators have complementary and integrated
expertise; are their leadership approach, governance and organizational
structure appropriate for the project?

Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach: Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the
project? Are potential problems, alternative strategies, and benchmarks for
success presented? If the project is in the early stages of development,
will the strategy establish feasibility and will particularly risky aspects
be managed? If the project involves clinical research, are the plans for 1)
Protections for Human Subjectss, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in
terms of the scientific goals and research strategy proposed?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

C.
Review Criteria for Shared Resource Core(s) (IF APPLICABLE): Each Shared Resource
Core must provide essential functions or services for at least two projects. The merit of each
shared resource core will be assessed based on the following
criteria:

Is
the proposed Shared Resource Core well matched to the needs of the overall
program? Does it provide essential facilities or services for two or more
scored research projects?

What is the overall quality of the proposed core services? Are
there adequate quality control processes proposed for the facilities or
services provided by the Shared Resource Cores (including procedures,
techniques, and quality control)? What are the criteria for prioritization and
usage of Core products and/or services?

Are
the qualifications, experience, and commitment of the Shared Resource Core
Director(s) and other key personnel adequate and appropriate for providing the
proposed facilities or services?.

Will
the proposed shared resource core(s) provide cost effective services to the Program? Are there
adequate plans to augment and/or complement an existing shared resource
supported by an NCI Cancer Center Support grant (P30), if applicable?

Is the environment for the shared resource core adequate to support the
program as proposed?

D. Progress
(for competing continuation [type 2] projects only).

Has adequate progress been made in both projects and
shared resource cores since the previous competitive review?

Were the previous specific aims accomplished, and are the
proposed research goals logical extensions of work during the current funding
period?

Has scientific synergy occurred, as indicated by joint
publications and new collaborative aims and/or projects?

As applicable for the project
proposed, reviewers will consider the following additional items in the
determination of scientific and technical merit, but will not give separate
scores for these items.

Protections for Human Subjects. For
research that involves human subjects but does not involve one of the six
categories of research that are exempt under 45 CFR Part 46, the committee will
evaluate the justification for involvement of human subjects and the proposed
protections from research risk relating to their participation according to the
following five review criteria: 1) risk to subjects, 2) adequacy of protection
against risks, 3) potential benefits to the subjects and others, 4) importance
of the knowledge to be gained, and 5) data and safety monitoring for clinical
trials.

For research that involves human subjects and meets
the criteria for one or more of the six categories of research that are exempt
under 45 CFR Part 46, the committee will evaluate: 1) the justification for the
exemption, 2) human subjects involvement and characteristics, and 3) sources of
materials.

Inclusion of Women, Minorities, and Children.
When the proposed project involves clinical research, the committee will
evaluate the proposed plans for inclusion of minorities and members of both
genders, as well as the inclusion of children.

Vertebrate Animals. The committee
will evaluate the involvement of live vertebrate animals as part of the
scientific assessment according to the following five points: 1) proposed use of
the animals, and species, strains, ages, sex, and numbers to be used; 2)
justifications for the use of animals and for the appropriateness of the species
and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting
discomfort, distress, pain and injury to that which is unavoidable in the
conduct of scientifically sound research including the use of analgesic,
anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and
5) methods of euthanasia and reason for selection if not consistent with the
AVMA Guidelines on Euthanasia.

Resubmission Applications. When
reviewing a Resubmission application (formerly called an amended application),
the committee will evaluate the application as now presented, taking into
consideration the responses to comments from the previous scientific review
group and changes made to the project.

Renewal Applications. When reviewing
a Renewal application (formerly called a competing continuation application),
the committee will consider the progress made in the last funding period.

Revision Applications. When
reviewing a Revision application (formerly called a competing supplement
application), the committee will consider the appropriateness of the proposed
expansion of the scope of the project. If the Revision application relates to a
specific line of investigation presented in the original application that was
not recommended for approval by the committee, then the committee will consider
whether the responses to comments from the previous scientific review group are
adequate and whether substantial changes are clearly evident.

Biohazards. Reviewers will assess
whether materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Additional Review Considerations

As applicable for the
project proposed, reviewers will address each of the following items, but will
not give scores for these items and should not consider them in providing an
overall impact score.

Budget and Period Support. Reviewers
will consider whether the budget and the requested period of support are fully
justified and reasonable in relation to the proposed research.

Select Agents Research. Reviewers
will assess the information provided in this section of the application,
including 1) the Select Agent(s) to be used in the proposed research, 2) the
registration status of all entities where Select Agent(s) will be used, 3) the
procedures that will be used to monitor possession use and transfer of Select
Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security
of the Select Agent(s).

Applications from Foreign Organizations.
Reviewers will assess whether the project presents special opportunities for
furthering research programs through the use of unusual talent, resources,
populations, or environmental conditions that exist in other countries and
either are not readily available in the United States or augment existing U.S.
resources.

When relevant, reviewers will be instructed to comment
on the reasonableness of the following Resource Sharing Plans, or the rationale
for not sharing the following types of resources. However, reviewers will not
factor the proposed resource sharing plan(s) into the determination of
scientific merit or impact/priority score, unless noted otherwise in the FOA. Program
staff within the NCI will be responsible for monitoring the resource sharing.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NOA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See also Section
IV.5. Funding Restrictions.

A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants
management officer is the authorizing document. Once all administrative and
programmatic issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.

A
final progress report, invention statement, and Financial Status Report are
required when an award is relinquished when a recipient changes institutions or
when an award is terminated.

Section
VII. Agency Contacts

We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research; peer
review; and financial or grants management issues.

Human Subjects Protection:Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness, and
comparative trials (Phase III). Monitoring should be commensurate with risk.
The establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their
institutions, on issues related to institutional policies and
local IRB rules, as well as local, State and Federal laws and regulations,
including the Privacy Rule. Reviewers will consider the data sharing plan
but will not factor the plan into the determination of the scientific merit or
the impact/priority score.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For
additional information, see https://grants.nih.gov/grants/gwas/.Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and distributing
unique model organism research resources generated using NIH funding or state
why such sharing is restricted or not possible. This will permit other
researchers to benefit from the resources developed with public funding. The
inclusion of a model organism sharing plan is not subject to a cost threshold
in any year and is expected to be included in all applications where the
development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Inclusion of Women, Minorities, and Children:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them. All investigators proposing research involving
human subjects should read the "NIH Policy and Guidelines" on the
inclusion of children as participants in research involving human subjects (https://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH
Public Access Policy Requirement:In accordance with the NIH Public Access Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html),
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigators NIH award. For more information, see the Public Access
webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department of
Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant
Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.

Healthy People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is
described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.